Meta-consent for the secondary use of health data within a learning health system: a qualitative study of the public’s perspective

Abstract

Background The advent of learning healthcare systems (LHSs) raises an important implementation challenge concerning how to request and manage consent to support secondary use of data in learning cycles, particularly research activities. Current consent models in Quebec were not established with the context of LHSs in mind and do not support the agility and transparency required to obtain consent from all involved, especially the citizens. Therefore, a new approach to consent is needed. Previous work identified the meta-consent model as a promising alternative to fulfill the requirements of LHSs, particularly large-scale deployments. We elicited the public’s attitude toward the meta-consent model to evaluate if the model could be understood by the citizens and would be deemed acceptable to prepare for its possible implementation in Quebec. Methods Eight focus groups, with a total of 63 members of the general public from various backgrounds were conducted in Quebec, Canada, in 2019. Explicit attention was given to literacy levels, language spoken at home and rural vs urban settings. We assessed attitudes, concerns and facilitators regarding key components of the meta-consent model: predefined categories to personalized consent requests, a dynamic web-based infrastructure to record meta-consent, and default settings. To analyse the discussions, a thematic content analysis was performed using a qualitative software. Results Our findings showed that participants were supportive of this new approach of consent as it promotes transparency and offers autonomy for the management of their health data. Key facilitators were identified to be considered in the implementation of a meta-consent model in the Quebec LHSs: information and transparency, awareness campaigns, development of educational tools, collaboration of front-line healthcare professionals, default settings deemed acceptable by the society as well as close partnerships with recognized and trusted institutions. Conclusions This qualitative study reveals the openness of a sample of the Quebec population regarding the meta-consent model for secondary use of health data for research. This first exploratory study conducted with the public is an important step in guiding decision-makers in the next phases of implementing the various strategies to support access and use of health data in Quebec.

Patients’ Willingness to Provide Their Clinical Data for Research Purposes and Acceptance of Different Consent Models: Findings From a Representative Survey of Patients With Cancer

“…This resonates with another German study with outpatients who generally support data donation in favor of public research institutions in EU countries with similar data protection standards (92%); only a minority of the participants approved data access to countries outside the EU (24%), which is a large share compared with our findings [6]. The high relevance of this aspect is consistent with studies of Canadian citizens [8,9]. However, further studies are needed to explore the exact kinds of misuse that make people fearful about international data transfers.…”

“…These findings indicate the relevance of the ability of data governance to protect clinical data, maximize accessibility (and usability) of data for research, and report transparently on the results of data use. These findings are largely consistent with previous literature that describes secure data use, public benefits through effective use by researchers, and transparency as important requirements for data sharing [3,8,14]. It may well be that participants value the reporting of results as an act of recognition and reciprocity.…”

“…When asked for consent, participants expected brief and understandable written information (616/838, 73.5%) about data use and preferred their primary care physician as a venue for informed consent (528/838, 63%) over providing consent upon hospital admission (174/838, 20.8%). This finding is underpinned by a qualitative study in which support by health care professionals was seen as an important facilitator [8].…”

“…Previous studies with citizens and patients have already shown that certain aspects seem to be crucial for supporting secondary use, such as who conducts the research (eg, academic or commercial), whether data are transferred to other countries, and what consent model is applied [2][3][4][5][6][7][8][9]. However, owing to varying research designs, for example, by examining different study units, applying different survey instruments, and being conducted in diverse health care systems, these studies, taken together, have heterogeneous results.…”

Patients’ and Members of the Public’s Wishes Regarding Transparency in the Context of Secondary Use of Health Data: Scoping Review

“…Therefore, while the potential of secondary use of health data for research purposes is seen as promising to many stakeholders in the academic and health care worlds, trust regarding data sharing in novel contexts should not be considered as a given [7]. Indeed, despite substantial evidence that most individuals support the secondary use of health data, this support is neither unanimous nor unconditional [6,[8][9][10][11]. Stakeholders including patients and members of the public express different needs that touch upon trust and agency [12].…”